• General Dermatology
  • Eczema
  • Alopecia
  • Aesthetics
  • Vitiligo
  • COVID-19
  • Actinic Keratosis
  • Precision Medicine and Biologics
  • Rare Disease
  • Wound Care
  • Rosacea
  • Psoriasis
  • Psoriatic Arthritis
  • Atopic Dermatitis
  • Melasma
  • NP and PA
  • Anti-Aging
  • Skin Cancer
  • Hidradenitis Suppurativa
  • Drug Watch
  • Pigmentary Disorders
  • Acne
  • Pediatric Dermatology
  • Practice Management

FDA holds off decision on psoriasis drug

Article

New York - The Food and Drug Administration (FDA) has held off making a decision on the psoriasis drug ustekinumab (Johnson & Johnson), until they receive certain risk-mitigation information, but will not require new studies, Reuters reports.

New York

- The Food and Drug Administration (FDA) has held off making a decision on the psoriasis drug ustekinumab (Johnson & Johnson), until they receive certain risk-mitigation information, but will not require new studies, Reuters reports.

The FDA has issued a Complete Response letter for ustekinumab, which is sometimes issued when the agency needs more time to adequately review a drug, requesting additional information to ensure the drug’s benefits outweight the risks, according to a Johnson & Johnson press release.

The company says the letter also requests a medication guide and communication plan as part of the risk-mitigation information, which Johnson & Johnson says will be addressed next month, as the focus this month is on bringing the drug to market.

Related Videos
© 2024 MJH Life Sciences

All rights reserved.